HomeCLINICAL TRIALS, STUDIES, REGISTRIES, DATA
CLINICAL TRIALS, STUDIES, REGISTRIES, DATA
Clinical trials, studies, data, and updates reported in Medical Device News Magazine.
Salubris Biotherapeutics Presents Positive 6-Month Data from Phase 1b Clinical Trial of JK07 in Late-Breaking Session at The Heart Failure Society of America Annual...
The data were presented in a late breaking oral session during the Heart Failure Society of America Annual Scientific Meeting 2023. JK07 is the first investigational antibody fusion protein and first selective ErbB4 agonist to enter clinical development for heart failure. Heart failure is a leading cause of morbidity and mortality globally, with estimates of more than 6 million patients affected by HFrEF and HFpEF in the US.
Neoadjuvant Study with LTX-315 In Early-stage Melanoma Patients to be Presented at the 15th Nordic Melanoma Meeting
The title of the presentation is: Neoadjuvant LTX-315 in combination with pembrolizumab in resectable stage III/IV melanoma (NeoLIPA trial): Protocol for a single center phase II open label study.
Amber Implants Announces Start of Clinical Trial with VCFix® Spinal System
This first-in-human clinical trial will assess the safety and effectiveness of the VCFix® Spinal System implant for patients suffering from vertebral compression fractures. The implant is provided with a user-friendly, single-use sterile surgical kit, ensuring perfect traceability and reducing the risk of infection.
Theradaptive Awarded DOD Clinical Trial Award of up to $7.4 Million
Commenting on the award, Theradaptive CEO and founder, Luis Alvarez, Ph.D. said, "The CDMRP Clinical Trial Award comes at a pivotal time for our company as we prepare for first in human clinical trials. Veterans and service members are disproportionally likely to suffer from traumatic extremity injuries or spinal degeneration and disc injury, and currently lack efficacious treatments with very few options. We have already demonstrated superior outcomes in preclinical studies, showing the promise of our technology. With this CTA award we are one step closer to providing new and improved therapies to patients and aligning with CDMRP's strategic goal of trying to increase post-injury quality of life by halting or slowing orthopedic disease progression in servicemembers and veterans."
Lipogems® Announces 140 Independent Peer Reviewed Publications with 5 Years of Follow up in Orthopaedics
Giorgio Ninzoli, President of Lipogems International. "The gold standard for evidence is 1 year follow up and we are excited to report 5 years follow up with positive results after a single injection of MicroFat."
Study Outcomes Could Provide Insights Into New Targeted Treatments to Manage this Challenging Disease
The study aims to determine if immediate biological preservation of patient-derived chordoma tumor tissue, collected intraoperatively and implanted for serial sampling in translational research, will provide new insights into the biological weakness of the disease and contribute to developing improved treatment therapies reports NICO.
Study Validates Lunit AI as a Game-Changer, Poised to Replace One Human Reader in Breast Cancer Screening
Utilizing Lunit INSIGHT MMG, an FDA-cleared and CE-marked AI solution for mammography analysis, this research backs AI's potential to replace one human reader under Europe's double reading guideline and underscores its capacity to alleviate the strain on radiologists.
MedAlliance Announces Enrollment of over 1,660 Patients in Landmark SELUTION DeNovo Study
SELUTION DeNovo Study is the largest DEB study ever initiated, involving up to 70 participating sites across 15 countries. Patients are randomized before any vessel preparation to reflect current medical practice and to reduce bias. The objectives of the study are to demonstrate non-inferiority at both one and five years, and superiority for target vessel failure (TVF) at five years.
Vitestro Starts Largest-scale Clinical Trial Globally for its Autonomous Blood Drawing Device, with Enrolment of First Patients in A.D.O.P.T.
Vitestro expects to obtain CE marking by the end of 2024. The first 350 patients have currently been enrolled the A.D.O.P.T. (Autonomous Optimization and Performance Tests for Blood Testing) Trial at study site Result Laboratorium in the Albert Schweitzer Hospital. Investigational partners, in addition to Result Laboratorium - Albert Schweitzer Hospital, are St. Antonius, OLVG Lab and Amsterdam UMC.
